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Applied Clinical Trials
A look into the current state of the eCTD format as well as its future in industry from a global standpoint.
From cable to digital, mobile phones to smart phones, dial-up to DSL, cable or wireless—it seems every time we turn around there is an evolved form of the technology we have just become accustomed to. Technological revolutions inevitably influence all of us, and the clinical trials industry has been no exception.
Reaching its 1000th electronic common technical document (eCTD) submission in July of 2008, Image Solution Inc.'s (ISI; Whippany, NJ) accomplishments showcase not only the company's business growth, but also serve as a representation of the growing transition taking place in industry.
Though not all technological advancements require an immediate change, eventually those who have not jumped on the bandwagon are often forced to do so.
Industry, particularly in the United States, is experiencing this forced shift with the Food and Drug Administration's (FDA) mandate requiring that all electronic submissions be in the eCTD format as of January 2008.
With the specifications of the eCTD submission format coming out in 2002, ISI made its first submission of this kind in January of 2003 and has experienced a substantial increase in submissions in the years to follow: 60 in 2004, 96 in 2005, 190 in 2006, 343 in 2007, and 526 as of the end of November 2008. ISI now anticipates about 700-800 eCTD submissions for 2009.
The eCTD submission format is designed to benefit both industry and agency. "On the industry end, duplication of efforts is a lot less now because you can take information in this format and use it over and over again, reducing redundancies," explained Jeanie Kwon, ISI's senior director of regulatory operations.
As for agency, rather than having to view multiple formats, eCTD presents the advantage of only having to deal with one.
If this submission format is intended to benefit industry as a whole, across multiple regions, why doesn't everyone make the transition?
Of course, "a lot of fear comes with change," Kwon offered, and "it's hard for companies to justify [using the eCTD format] to management without agencies saying that you must."
But that's not to say you can't teach an old dog new tricks. In an effort to alleviate the burden of transferring formats, ISI offers educational programs and eCTD workshops. The company also provides regular consultants that come in and review clients' processes in order to give recommendations on moving forward with the use of eCTD submissions.
Beyond the common fears that often accompany change, there are many companies, particularly smaller ones, that simply do not have the bandwidth or capacity to make electronic submissions, Kwon explained.
Being developed for the intended purpose of streamlining the submission process across multiple regions, the goal of this particular format would not be achieved unless it continued to grow within and among the various regions involved—the United States, European Union, and Japan.
"The biggest challenge industry has been having from one region to the next is that although content was the same, each region has had different formats," explained Kwon.
While it may seem the United States is the furthest along with the implementation of the eCTD format because of the FDA's 2008 mandate, it still has a ways to go as well. With investigational new drug applications (INDs), about 90% are still in paper format, according to Kwon, and about half of new drug applications (NDAs) are received in electronic format that's not specifically eCTD.
Though Japan has yet to make any requirements, it is able to accept eCTD submissions. The country has received 52 eCTD applications in total as of 2007, according to the Proceedings of the International Conference on Harmonization Tokyo Symposium.
Similar to the FDA, the EMEA has also set out an implementation strategy that requires the use of the eCTD format for all electronic submissions as of January 1, 2010. In addition to the mandate, prior to this specified date all submissions that are non-eCTD must follow new guidelines.
"The 2008 mandate put a spark under people and it was a big driver. I think we'll see that also in Europe," Kwon noted.—Marissa Shapiro